Efficacy and safety of Alefacept in combination with Tacrolimus, Mycophenolate Mofetil and Steroids in de-novo kidney transplantation – a multicenter, randomized, double-blind, placebo controlled, parallel group studyShort Title: Proof of Concept with Alefacept in Kidney TransplantationProtocol for Phase 2 Study of Alefacept

Conditions: kidney transplantation
MedDRA version: 9.1Level: LLTClassification code 10023438Term: Kidney transplant

Registration Number: EUCTR2007-002092-14-HU

Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Subject is eligible for the study if all of the following apply:
1. Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or re-transplantation.
2. Male or female subject at least 18 years of age and younger than 65 years.
3. Subject receiving a kidney transplant from a non-HLA identical living donor or a deceased donor between 5 and 59 years of age with compatible AB0 blood type.
4. Female subjects of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. Effective birth control is defined as surgically sterilized, hormonal contraception or total abstinence at the discretion of the investigator in cases where age, career, lifestyle or sexual orientation ensures compliance of the subject.
5. Subject has been fully informed and has given written informed consent. Subject unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject will be excluded from participation if any of the following apply:
1. Subject has a PRA grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons.
2. Subject will receive a kidney transplant from a non-heart beating donor.
3. Subject will receive a kidney from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine >1.5 mg/dL (United Network for Organ Sharing UNOS expanded criteria donor).
4. Subject has previously received or is receiving an organ transplant other than kidney.
5. Cold ischemia time of the donor kidney is = 30 hours.
6. Subject is pregnant or breastfeeding.
7. Subject has significant liver disease, defined as having continuously elevated AST and/or ALT levels greater than 2 times the upper value of the normal range.
8. Subject has known hypersensitivity to alefacept, tacrolimus, macrolide antibiotic, mycophenolate mofetil, corticosteroids or any of the product excipients.
9. Subject has received intravenous immunoglobulin (IVIG) therapy in the three months prior to first dose of study drug.
10. Subject requires initial sequential or parallel therapy with immunosuppressive antibody preparation.
11. Subject requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation.
12. Subject or donor is known to be HIV positive.
13. Subject with malignancy or history of malignancy in the past five years, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
14. Subject has significant, uncontrolled concomitant infections or any other unstable medical condition that could interfere with the study objectives.
15. Subject is participating or has participated in another clinical trial and/or is taking or has taken an investigational drug in the past 28 days.
16. Subject is unlikely to comply with the visit schedule in the protocol.
17. Subject has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator.
18. Subject or donor with history, clinical evidence, or confirmed positive laboratory tests of acute or chronic hepatitis B (i.e. positive HbsAg) or C (i.e positive HCV serology) infection.
19. Subject will undergo retransplantation due to acute rejection within the first postoperative year following immunosuppressive triple therapy.
20. Subject treated with rituximab in the nine months prior to screening.
21. Subject is sensitive to iodine.
22. Subject is receiving any tacrolimus formulation other than Prograf.